(111 days)
The MicroVention MicroPlex Coil System (MCS) is intended for endovascular embolization of those intracranial aneurysms that, because of their morphology, their location or the patient's general medical condition, are considered by the treating neurosurgical team to be very high risk for management by traditional operative techniques, or inoperable.
The MicroVention MicroPlex Coils are available in two versions: (1) Complex-shaped configurations, and (2) helically-shaped coil configurations of various diameters and dimensions. These embolization coils are fabricated from a platinum alloy wire, which is first wound into a primary coil, and then formed into the secondary complex or helical shape. The MicroPlex Coils are provided attached to a Delivery Pusher. The MicroPlex Coil is detached from the Delivery Pusher by applying pressure force, with radiographic contrast media, at the proximal end of the Delivery Pusher. Once the embolization coil is detached, the Delivery Pusher is then removed from the microcatheter and discarded.
The provided text describes the MicroVention, Inc. MicroPlex Coil System, but it does not contain any information regarding acceptance criteria or a study proving that the device meets specific performance metrics.
The document details the device's summary of safety and effectiveness for its 510(k) premarket notification. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with defined acceptance criteria and performance results.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, or specific study types based on the given text.
The document primarily provides:
- Device Identification: Name, classification, and contact information.
- Predicate Devices: A list of previously cleared devices to which substantial equivalence is claimed.
- Device Description: Information on the materials (platinum alloy wire), configurations (complex-shaped and helically-shaped), and detachment mechanism (pressure force with radiographic contrast media).
- Intended Use: Endovascular embolization of intracranial aneurysms considered high-risk or inoperable.
- Technological Characteristics Comparison: Highlights similarities in materials and configurations, but notes the difference in coil detachment methods.
- Nonclinical Tests: Mentions "tensile strength, coil detachment, biocompatibility, and clinical simulation testing in animals" were performed. However, it does not provide any specific results, acceptance criteria for these tests, or detailed methodology. It only states that these tests "demonstrated that the MicroVention MicroPlex Coil System has performance substantially equivalent to that of the predicate devices."
- FDA Clearance Letter: Confirms the 510(k) clearance based on substantial equivalence.
Without specific performance data and acceptance criteria from a study, I cannot fulfill the request for a detailed breakdown of the device's performance against such criteria.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).